The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.

Tuberculosis (TB) remains a major public health problem. In extra-pulmonary forms, evidence of bacteriological cure is difficult to be obtained raising the need for other therapeutic assessment tools. 18F-Fluoro-deoxy-glucose (FDG) is a glucose analogue widely used in Positron Emission Tomography (PET). Its uptake is high in cancer cells and in inflammatory cells, especially in active TB foci. The hypothesis is a decrease in the uptake of FDG in the foci of TB during treatment permitting a non-invasive monitoring of therapeutic response. The main objective is to describe the evolution under treatment of the FDG uptake in PET imaging in TB foci in patients cured from lymph node and bone TB. Secondary objectives are to compare the decrease of FDG uptake according to type of location, to define the frequency of localizations revealed by FDG-PET and their impact on therapeutic management at the beginning and the end of treatment, and to describe the evolution of PET in patients not cured.

Condition or disease

Intervention/treatment

Phase

Extrapulmonary TuberculosisLymph Node TuberculosisBone Tuberculosis

Other: Positron Emission Tomography with 18F-Fluoro-deoxy-glucose

Not Applicable

Detailed Description:

Longitudinal observational multicenter pilot study. 55 patients to be included Total duration of the study: 51 months. Inclusion period: 27 months Follow up period: 18 to 24 months Number of participating centers: 11 Average number of inclusion per month per center: 1-2

ΣSUVmax variations between the beginning and end of treatment and during follow-up post-treatment, in patients considered cured [ Time Frame: 6 to 18 months ]

To measure FDG uptake and evolution, the ΣSUVmax will be used. SUV ("Standard Uptake Value") is defined as tissue concentration of FDG / administered FDG dose / patient weight. ΣSUVmax is the sum of the maximum SUV measured in every TB foci. ΣSUVmax variations between the beginning and the end of treatment, and 6 months later in cases of persistent uptake at the end of treatment will be studied in patients considered cured

Secondary Outcome Measures :

Change in SUVmax differences in the lesions according to their location in cured patients. [ Time Frame: 6 to 18 months ]

SUV variations between the beginning and the end of treatment, and 6 months later in cases of persistent uptake at the end of treatment will be studied in the lesions according to their location in cured patients

Variations ΣSUVmax and SUVmax in individual lesions in patients not cured. [ Time Frame: 6 to 18 months ]

ΣSUVmax variations between the beginning and the end of treatment, and 6 months later in cases of persistent uptake at the end of treatment will be studied in patients not cured.

Frequency, type and consequences on the therapeutic management of lesions revealed by FDG-PET. [ Time Frame: 6 to 18 months ]

Changes in composition or treatment duration will be identified and reported to the information provided by FDG-PET during the study.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:

18 Years and older (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Adults

Affiliated to a social security system or "AME"

Patient informed of the objectives and constraints of the study and giving informed consent

Patient can keep lying valid at least 30 minutes

Patient not HIV infected or, if infected, with CD4 counts> 200/mm3 for at least 3 months